Resumen

Subestudio A: El objetivo de este estudio es conocer la seguridad y los efectos de dos nuevas vacunas para el RSV (RSVpreF) e influenza (modRNA qIRV) cuando se administran como una inyección única en comparación con la administración por separado. El RSV y la influenza causan infecciones, principalmente en otoño e invierno. Estas vacunas están siendo desarrolladas para ayudar a prevenir la enfermedad por virus sincicial respiratorio (RSV) e influenza (gripe). Este estudio busca participantes que: * tengan 60 años o más * estén sanos o tengan enfermedades crónicas bien controladas * no hayan recibido la vacuna antigripal en los últimos 120 días * y acepten estar presentes en todas las visitas del estudio, procedimientos y extracciones de sangre. Los participantes se dividirán en 2 grupos. El Grupo 1 recibirá la inyección combinada de RSVpreF más qIRV, después de lo cual los participantes recibirán el placebo (una inyección que no contiene medicamento). El Grupo 2 recibirá primero la inyección de qIRV y luego RSVpreF con 1 mes de diferencia. Los investigadores examinarán las experiencias de los participantes que reciban las vacunas del estudio. Esto ayudará a los investigadores a determinar si las vacunas del estudio son seguras y producen una respuesta inmune similar. Los participantes estarán involucrados en este estudio durante 2 meses. Durante este tiempo, los participantes tendrán 3 visitas en la clínica del estudio. El Subestudio B investigará 2 formulaciones de RSVpreF + qIRV de diferentes volúmenes y osmolalidades (concentraciones). Estas formulaciones serán evaluadas en cuanto a seguridad, tolerabilidad e inmunogenicidad, con el objetivo de seleccionar una formulación para estudios posteriores. Este estudio busca participantes que: * tengan 50 años o más * estén sanos o tengan enfermedades crónicas bien controladas * no hayan recibido la vacuna antigripal en los últimos 180 días * y acepten estar presentes en todas las visitas del estudio, procedimientos y extracciones de sangre. Los participantes se dividirán en 2 grupos. El Grupo 1 recibirá RSVpreF más qIRV en una formulación de 1,0 mL mientras que el Grupo 2 recibirá RSVpreF más qIRV en una formulación de 0,5 mL. Los investigadores examinarán las experiencias de los participantes que reciban las vacunas del estudio. Esto ayudará a los investigadores a determinar si las vacunas del estudio son seguras, bien toleradas y producen una respuesta inmune similar. Los participantes estarán involucrados en este estudio durante 1 mes. Durante este tiempo, los participantes tendrán 2 visitas en la clínica del estudio.

Descripción detallada

Subestudio A: Este estudio está diseñado para evaluar la seguridad, tolerabilidad e inmunogenicidad de vacunas combinadas respiratorias candidatas. Este estudio inicial se llevará a cabo como un subestudio de Fase 1b, de grupos paralelos, aleatorizado, controlado con placebo y ciego para el observador, de RSVpreF y una vacuna de ARN modificado con nucleósidos (qIRV) contra el RSV y la influenza cuando se administran como vacuna combinada y cuando se administran por separado. Adultos sanos de ≥60 años de edad serán aleatorizados 1:1 a uno de los siguientes grupos: Grupo 1: combinación (RSVpreF + qIRV) seguida de placebo; o Grupo 2: administración secuencial de qIRV seguida de RSVpreF administrada con 1 mes de diferencia. El Subestudio B se llevará a cabo como un subestudio de Fase 1b, de grupos paralelos, aleatorizado y ciego para el observador, de RSVpreF y una vacuna de ARN modificado con nucleósidos (qIRV) contra el RSV y la influenza, administradas como vacuna combinada en una formulación de 1,0 mL y en una formulación de 0,5 mL. Adultos sanos de ≥50 años de edad serán aleatorizados 1:1 a uno de los siguientes grupos: Grupo 1: combinación (RSVpreF + qIRV) formulación de 1,0 mL; o Grupo 2: combinación (RSVpreF + qIRV) formulación de 0,5 mL. Aproximadamente 100 participantes serán aleatorizados dentro del grupo de 50 a 64 años, y 100 participantes de ≥65 años de edad serán aleatorizados.

Elegibilidad

Edad mínima: 50 YearsSexo: ALL

Criterios de inclusión

Substudy A:
Participants ≥60 years of age at study enrollment.
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol.
Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season \>120 days before study intervention administration.
Participants ≥50 years of age at study enrollment.
Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving and having signed the informed consent as described in the protocol, which includes complying with the requirements and restrictions listed in the ICD and in this protocol.
Receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season or 2022 southern hemisphere season \>180 days before study intervention administration.

Criterios de exclusión

A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of any licensed RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
Receipt of any licensed influenza vaccine ≤120 days before study enrollment, or planned receipt throughout the study.
Participation in other studies involving an investigational RSV or mRNA influenza vaccine at any time prior to enrollment, and thereafter until study completion, regardless of vaccine assignment.
Participation in any other interventional studies within 28 days before study enrollment through study completion.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Substudy B
A confirmed diagnosis of RSV infection or influenza ≤120 days before study intervention administration.
History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate IM injection.
Serious chronic disorder, including metastatic malignancy, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration, or planned receipt throughout the study.
Receipt of any RSV vaccine at any time prior to enrollment, or planned receipt throughout the study.
Receipt of any influenza vaccine ≤180 days before study enrollment, or planned receipt throughout the study.
Participation in other studies involving an investigational RSV vaccine or mRNA influenza vaccine at any time prior to enrollment, and thereafter until study completion, regardless of vaccine assignment.
Participation in any other interventional studies within 28 days before study enrollment through study completion. Participation in purely observational studies is acceptable.
Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.

Intervenciones

biological

RSVpreF+qIRV

RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B combined with Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)

biological

qIRV

Quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 strains as recommended for the influenza season (2 A strains, 2 B strains)

biological

RSVpreF

RSVpreF containing 2 stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B

drug

Placebo

0.9% saline for injection

biological

RSVpreF + qIRV 1.0 mL formulation

RSVpreF containing 2 Stabilized RSV prefusion F antigens, in equal amounts from virus subgroups A and B plus qIRV Encoding HA of 4 strains as recommended for the influenza season (2 A strains and 2 B strains) plus sterile water as diluent for injection

biological

Estudio para evaluar la seguridad, tolerabilidad e inmunogenicidad de vacunas combinadas respiratorias candidatas en adultos mayores

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

RSVpreF+qIRV

qIRV

RSVpreF

Placebo

RSVpreF + qIRV 1.0 mL formulation

RSVpreF + qIRV 0.5 mL formulation

Ubicaciones

Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

Patrocinadores